US Patent

US11964055 — Orodispersible dosage unit containing an estetrol component

Formulation · Assigned to Estetra SRL · Expires 2036-06-17 · 10y remaining

Vulnerability score 55/100 Moderate — design-around opportunities exist

What this patent protects

This patent protects an orodispersible solid pharmaceutical dosage unit containing estetrol, which can be obtained through a specific manufacturing process.

USPTO Abstract

The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit consisting of: 0.1-25 wt. % of estetrol particles containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and 75-99.9 wt. % of one or more pharmaceutically acceptable ingredients; the solid dosage unit comprising at least 100 μg of the estetrol component; and wherein the solid dosage unit can be obtained by a process comprising wet granulation of estetrol particles having a volume weighted average particle size of 2 μm to 50 μm. The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.

Drugs covered by this patent

Patent Metadata

Patent number
US11964055
Jurisdiction
US
Classification
Formulation
Expires
2036-06-17
Drug substance claim
No
Drug product claim
Yes
Assignee
Estetra SRL
Source
FDA Orange Book + USPTO grounding via Google Patents

Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.

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